Astrid Friedrich

- Digitalization of weighing and dispense in production. managing a 2 Million budget: i) Re-design production and SAP processes iv) implementing a new WDS Software and hardware v) implementing machine learning/AI techniques - Packaging: DoE for serialisatzion reduced transfer- activities by 90% - Automated data exchange with customers, data entry reduced to the max - Development of a companywide SixSigma investigation procedure - Packaging: Aligning workflows with customer – KPI up from 10% to 98%

- Developing, implementing and managing the Site process validation for two process transfers, one of them a 3rd party product. - Establish, write, maintain complex validation protocols. - Development of strategies for statistical process validation concepts: i) DoE for bioburden ii) Worst case matrix approach - Lead the process validation team. - Active participation in interdisciplinary and global work groups on process validation topics.

Statistical process monitoring Statistical analyses in Minitab and Simca (MVDA) Development of strategy for aligning QbD with IT rollouts (Discoverant/OsiPi) Presentation and support of Audits Projects: 1. Manager for the data-consolidation in Access 2. Project Manager of Discoverant Vienna and sub-lead in global Discoverant projects 4. SixSigma Green Belt Projects: 4a. Yield improvement by customizing the chromatography gel 4b. Re-design monitoring process incl. change management

- Material qualification according to GMP and EU, plus USA Pharmacopoeia. - Define specifications and creating the LIMS testing program. - Handling complaints, Change Controls and supporting audits. - Review of regulatory submission files. - Interfacing with Purchasing and Planning, R&D, TS, Production, Regulatory department and manufacturers. - SixSigma Green Belt training.